RecruitingPhase 3ACTRN12611000474954

A Randomised Phase III Study of Elacytarabine vs. Investigator’s Choice in Patients with Late Stage Acute Myeloid Leukaemia

A Randomised Phase III Study in Patients with Late Stage Acute Myeloid Leukaemia, comparing the efficacy, measured as overall survival (OS), of elacytarabine and investigator’s choice.


Sponsor

Clavis Pharma ASA

Enrollment

350 participants

Start Date

Aug 17, 2010

Study Type

Interventional

Conditions

Summary

This study compares the safety and effectiveness of different types of chemotherapy to treat late stage acute myeloid leukaemia. Who is it for? You can join this study if you are aged 18 years or over and have been diagnosed with acute myeloid leukaemia, for which you have undergone two or three previously unsuccessful chemotherapy regimens. Trial details In this study, participants are randomly (by chance) divided into two groups. One group will receive chemotherapy with the drug, Elacytarabine. This will be administered intravenously (into the vein) continuously for 3 days every 3 weeks. The investigator wil decide how long it is beneficial for you to receive treatment.The other group will receive one of a number of other chemotherapy regimens used to treat leukaemia. The treatment administered will be selected by the treating doctor based on your condition. Participants will be regularly monitored in order to determine the safety and effectiveness of treatment.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing a chemotherapy drug called Elacytarabine against other standard chemotherapy options for people with late-stage acute myeloid leukaemia (AML) — a type of blood cancer — that has come back or has not responded to previous treatment. Elacytarabine works differently from standard treatments and may work even when cancer cells have become resistant to other chemotherapy drugs. Participants will be randomly assigned to one of the two treatment groups. You may be eligible if: - You are 18 years or older - You have confirmed AML that has been treated with two or three previous chemotherapy regimens without achieving lasting remission - Your cancer is currently active in the bone marrow or blood You may NOT be eligible if: - You have significant ongoing side effects from previous chemotherapy - You have serious liver or kidney problems - You have active, uncontrolled heart disease - You have received anti-leukaemia treatment within the past 4 weeks Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Elacytarabine continous infusion days 1-5, every 3 weeks, dose 2000 mg/m2/d. 1-2 treatment courses should be administered for remission induction, and 1-2 courses for consolidation. Patients who ben

Elacytarabine continous infusion days 1-5, every 3 weeks, dose 2000 mg/m2/d. 1-2 treatment courses should be administered for remission induction, and 1-2 courses for consolidation. Patients who benefit from the treatment may receive repeated courses of study drug at the discretion of the investigator, even if remission is not attained.


Locations(12)

Ireland

Italy

Norway

Poland

Romania

Spain

United Kingdom

United States of America

Belgium

Germany

Canada

France

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ACTRN12611000474954